Do you want to help improve the lives of millions of people?
We are developing cutting edge technology to reinvent the treatment of heart failure globally. If you are interested in joining a dynamic team that is working hard to change the world for the better, we’d love to talk to you.
As a Process Engineer at FIRE1 you will play a crucial role in advancing our manufacturing processes from prototype/ small volumes to scalable, consistent production for our pivotal trial. You will focus on identifying and resolving bottlenecks, improving yields, and fostering cross-functional collaboration between Manufacturing, R&D, and Quality Assurance. In addition, you will leverage lean manufacturing principles, theory of constraints, Six Sigma, DMAIC and/or Shainin principles to enhance operational efficiency and product quality.
This role is offered on a 12-month fixed term contract basis, and reports to the Manufacturing Manager.
Responsibilities
- Monitor and report on key performance indicators (KPIs) and drive continuous improvement initiatives related to documentation, safety, quality, equipment available time, throughput and yield.
- Investigate yield issues and collaborate with cross-functional teams using tools like Six Sigma, DMAIC, Shainin, etc. to propose and implement effective solutions that drive yield improvements.
- Troubleshoot equipment issues and continuously evolve our preventive maintenance and IQOQ practices.
- Conduct training and provide guidance to team members on process optimization techniques and best practices.
- Interface directly with the process development team to capitalize on key learnings and implement solutions that could improve manufacturing.
- Drive alignment among cross-functional teams, including Quality Assurance and R&D, to ensure all stakeholders are informed, engaged, and supportive.
- Develop and maintain accurate documentation of processes and ensure all documentation meets FIRE1 QMS and regulatory requirements, supporting the achievement of the business quality objectives.
- Resolve non-conformances by investigating root causes and implementing fixes that eliminate the problem.
Qualification & Experience
Essential
- Bachelor’s degree in engineering, science, manufacturing, or a related field.
- Minimum of 3 years of experience in process engineering within a manufacturing environment, preferably in the medical device industry.
- In-depth knowledge of manufacturing processes, ideally manual assembly of medical devices.
- Statistical and data analysis proficiency, to analyse and optimize processes.
- Equipment/ Fixture Design: Solidworks or other CAD experience, GDT principles desirable.
- Exposure to Six Sigma, DMAIC, Shainin or other root cause investigation methodologies.
- Ability to work effectively with diverse teams.
- Strong written and verbal communication skills to present technical concepts clearly to both technical and non-technical audiences.
- Capability to lead projects, mentor junior staff, and influence stakeholders while maintaining positive relationships.
- Strong analytical and critical thinking skills to identify obstacles and develop effective solutions.
- Flexibility to adapt to changing requirements and priorities in a fast-paced manufacturing environment.
- Proficiency in creating detailed technical documentation, validation protocols, and reports.
Desirable (but not essential):
- Proven experience in scaling up manufacturing processes and leading initiatives related to lean manufacturing and the theory of constraints
- 7+ years’ experience in a similar role (potential for the role to become Senior Process Engineer for a candidate with the right experience)
- Knowledge of FDA regulations and quality management systems related to Class III medical devices
- Knowledge of lean manufacturing methodologies and principles e.g. cell systems, single piece flow, kanban, etc. priorities.
- Service orientation.
Benefits
- 25 days annual leave
- Competitive health insurance plan with VHI
- Pension 8% employer contribution
- Employee share ownership programme
- Discretionary bonus plan
- Discounted gym membership at DCU & UCD gyms
- Taxsaver Commuter Tickets & Bike to Work Scheme
- EAP (Employee Assistance Programme)
- Employer funded Sports & Social Committee
Our Values
We are a team – We are a diverse team who respect each other’s opinions. We work and learn together in an open and honest way to achieve our ambitious purpose.
We care about our patients – We are determined to give our patients their normal back and strive to continuously improve the patient experience. We appreciate the sacrifice they make to be in our study.
We are pioneers – We embrace the uncertainty of trying something new & appreciate the privilege we have to build a company that will improve millions of lives.
We are ambitious – We are purpose-driven & will deliver the market leading, self-management product for heart failure, to give millions of patients their normal back.